Month: June 2016

A North Carolina woman who took Taxotere has filed suit against the makers of cancer drug Taxotere, alleging that it caused her disfiguring permanent alopecia.

The case is Kathy Mottola v. Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC, Case 3:16-cv-00255-RJC-DCK. The emerging litigation is ripe for a motion to consolidate them into a federal multi-district litigation docket, because complaints involving Taxotere (Docetaxel) have been filed in multiple jurisdictions, including US District Courts in Illinois, North Carolina, Florida, Mississippi, Kansas, Louisiana and Colorado.

Defendant Sanofi S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Paris, France.

Defendant Aventis Pharma S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Antony, France.

Defendant Sanofi-Aventis U.S. LLC is a Delaware limited liability company, which has its principal place of business at 55 Corporate Drive, Bridgewater, New Jersey.

Taxotere is a drug used to treat various forms of cancer, including but not limited to breast cancer. It is a part of a family of drugs commonly referred to as Taxanes.

Partial mastectomy

On January 4th, 2013, Plaintiff Kathy Mottola underwent a right breast partial needle mastectomy performed by Richard White at Carolinas Medical Center in Charlotte, North Carolina. A biopsy had demonstrated invasive mammary carcinoma in her right breast. Following the mastectomy, she met with her oncologist to discuss further treatment.

Neither Mottola nor her treating healthcare providers were aware of or informed by Defendants that disfiguring permanent alopecia can occur following treatment with Taxotere. Accordingly, she underwent chemotherapy that included Taxotere. Following the completion of chemotherapy on May 23, 2013, she suffered from disfiguring permanent alopecia.

Despite the fact that Defendants disclosed risks associated with Taxotere and permanent alopecia to patients and regulatory agencies in other countries, they failed to either alert Plaintiff, the public, and the scientific community in the US or to perform further investigation into the safety of Taxotere. Defendants failed to update the warnings forthe drug, and failed to disclose the results of additional studies as Defendants learned new facts regarding the defects and risks of their product.

Thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning and without any additional benefit.

Xarelto Lawsuit Filed Against Makers of Xarelto

A husband and wife from Ohio filed suit against the makers of the drug Xarelto, charging that it directly caused the woman to suffer significant health issues, including a potentially fatal bleeding episode and anemia.

While it was initially heralded as a wonder drug, Xarelto has since accumulated more than 3,000 lawsuits against it, many with similar claims. The plaintiffs claim that they were placed at undue risk to suffer catastrophic bleeding events, some of which proved fatal, by taking the drug.

$150,000 in damages

The Ohio couple is seeking more than $150,000 in damages to defray the cost of existing medical expenses and the future care for her injuries. Originally, she was prescribed the new-generation anticoagulant because she suffers from a cardiac disorder known as atrial fibrillation. This can often place individuals at a heightened risk for stroke.

According to the claim, she began experiencing difficulties within two months of beginning the Xarelto regimen. A rupture in her intestinal blood vessels was continuing to bleed, due to the anti-clotting action of the drug. The suit claims that this contributed directly to anemia and other factors that have substantially impaired her ability to live a full life.

The FDA approved Xarelto for public use in 2011 as a new way to prevent blood clots.

Originally, its stated uses included treatment for those suffering from pulmonary embolism or deep vein thrombosis and patients recovering from hip or knee replacement surgeries. However, the approved uses soon expanded to include it as a preventative measure in the treatment of atrial fibrillation.

At least 1,239 Benicar side effects lawsuits have been filed against Allergan plc and Warner Chilcott Ltd., according to Lawyers and Settlements. This is according to their Form 10-K filing with the US Securities and Exchange Commission submitted in February.

After completing multiple tests and rigorous studies, the Food & Drug Administration (FDA) concluded that Benicar, generically known as olmersartan medoxomil, is an unreasonably dangerous drug that is the cause of sprue-like enteropathy.

The FDA concluded in 2013 that Benicar, a drug commonly prescribed to control blood pressure, was responsible for 23 serious reports of health related problems, which in some cases required hospitalization. FDA warnings were distributed to the leading manufacturers of Benicar including Daiichi Sankyo Inc. (Daichi), and Forest Laboratories (Forest). Following the release of the FDA warning, Daiichi, and Forest continued manufacturing and promoting Benicar to consumers and their doctors, despite the fact that it had been blacklisted as a dangerous drug.

Four products at issue

The four olmesartan products at issue in this litigation are: Benicar®, Benicar HCT®, Azor®, and Tribenzor®. With respect to each of these products, Defendants exaggerated their benefits and understated, omitted and/or failed to adequately warn patients and physicians about the risks associated with such products.

Plaintiffs have suffered personal injuries as a direct and proximate result of Defendants’ conduct and misconduct in connection with the design, development, manufacture, testing, packaging, promotion, advertising, marketing, distribution, labeling, warning, and sale of the olmesartan products.

Plaintiffs’ injuries are serious, longstanding, and permanent, resulting in multiple hospitalizations and even death in some cases. Had Plaintiffs or Plaintiffs’ health care professional(s) been properly warned by Defendants about the risks from ingesting Defendants’ olmesartan products, the Plaintiffs would not have ingested these drugs and/or would have ceased use of the olmesartan products.

By Kay Van Wey, Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization

Attorney Kay Van Wey

There is concern in the medical community about Bair Hugger® Therapy used during surgeries involving implants because these surgeries often carry a high risk of contamination. According to multiple studies, the forced-air warming systems could possibly carry a higher risk for contaminating surgical sites than other warming methods.

Bair Hugger Therapy works by using temperature management systems that force warm air throughout to prevent and treat hypothermia in patients during surgery. Hypothermia during surgery can lead to blood loss, infections and prolonged hospital stays.

The blankets were invented by Dr. Scott D. Augustine, and they are sold along with warming units and accessories through his company, Augustine Biomedical and Design. Bair Hugger® Therapy is used on more than 180 million patients since being introduced in 1988. More than 80 percent of hospitals in the United States use them today.

Dr. Augustine now states that the blankets should not be used in patients who have had implants (including knee and hip implants and artificial heart valves) because they can potentially spread bacteria linked to infections.

FDA Not Recalled Bair Hugger® Blankets

The FDA still hasn’t issued a recall of these medical devices even though many adverse effects have been reported to them. Most reports involve burns from prolonged exposure to heat during surgery or cold air blowing during surgery when the device malfunctioned.

Patients who have developed an infection after surgery that involved the use of Bair Hugger® Therapy have filed lawsuits against the manufacturers, claiming they knew about the risk and attempted to conceal evidence. Compensation for damages, medical expenses, pain and suffering, lost wages and punitive damages could be awarded.

The proceeding convened its most recently monthly Status Conference, when it was reported that 383 cases were pending in the federal litigation. An addition 39 claims that put forth similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The involved manufacturers and distributors are Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).

Fluoroquinolone Side Effects

Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat pneumonia, sexually transmitted diseases, E. coli, staph and other serious bacterial infections. Plaintiffs who have Levaquin lawsuits or other cases pending in the District of Minnesota claim that the manufacturers of these medications failed to provide doctors and patients with adequate warnings about their potential to cause serious nerve damage, including permanent peripheral neuropathy. Mention of these complications was added to the drugs’ labeling in 2004. However, the U.S. Food & Drug Administration (FDA) ordered their manufacturers to strengthen the labels in 2013 to better reflect the rapid onset of symptoms, as well as the potential for permanence. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

Last month, the FDA ordered that further modifications be made to the labels for fluoroquinolone medications, this time updating the boxed warning to state that the risks posed by the drugs outweigh their benefits for patients with certain uncomplicated infections when other treatment options are available. The agency acted after a review confirmed that fluoroquinolone antibiotics are associated with a number of serious side effects, including those involving the tendons, muscles, joints, nerves and central nervous system. These complications are potentially permanent and can occur together, the FDA said.

A drug commonly used to treat pain, epilepsy, anxiety and other brain health disorders may be associated with an increased risk of major birth defects, according to a study published in the May 18, 2016, online issue of Neurology®, the medical journal of the American Academy of Neurology.

The drug pregabalin is approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, such as pain from diabetic neuropathy or pain after shingles or spinal cord injury. It is also used for generalized anxiety disorder and other mental health issues. This is called off-label prescribing.

Lyrica, made by Pfizer, has been the target of extensive litigation. In 2009, for example, parent company Pfizer agreed to pay $2.3 billion to the Department of Justice for illegally promoting sales of a Lyrica dosage. This charge revolved around the fact that manufacturers urged doctors to prescribe Lyrica for so-called “off-label” use.

The study collected information in seven countries from 164 women who took pregabalin during a pregnancy and 656 pregnant women who were not taking any anti-seizure drugs. The women or their practitioners were then contacted again after their expected date of delivery.

Birth defects 3X more likely

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of the women who did not take anti-seizure drugs. Seven of the 116 pregnancies in women taking anti-seizure drugs, or 6 percent, had major birth defects, compared to 12 of 580 pregnancies, or 2 percent, in women who did not take the drug. Birth defects due to chromosomal abnormalities were not included in these results.

The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. The women taking pregabalin were six times more likely to have a pregnancy with a major defect in the central nervous system than women who were not taking the drug, with four CNS defects out of 125 pregnancies, or 3.2 percent, compared to three CNS defects out of 570 pregnancies, or 0.5 percent.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression, anxiety, bipolar disorder and psychosis, five were taking it for epilepsy and one was taking it for restless leg syndrome.

A total of 77 percent of the women started taking pregabalin before they became pregnant. The women in the study stopped taking the drug at an average of six weeks into their pregnancies. Of the women taking pregabalin, 22, or 13 percent, were also taking another anti-seizure drug.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.

Winterfeld said, “Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

Pradaxa was released on the market for use by consumers in 2010 by Boehringer Ingelheim.

Pradaxa became the focus of public attention, as it was the subject of more than 3,500 adverse event reports with fatalities in over 750 of them. It subsequently became the focus of over 4,000 lawsuits.

$650 million settlement

Rather than go to trial, Pradaxa’s maker opted to settle all the lawsuits with a $650 million settlement. It is the hope of many of the plaintiffs in the Xarelto cases that they will also be the beneficiaries of a settlement by the makers of Xarelto.

Xarelto defendants include Janssen Pharmaceuticals and Bayer AG, the former of which is a subsidiary of the Johnson and Johnson Corporation. The U.S. Judicial Panel on Multidistrict Litigation (JPML) decreed that because the cases filed were strikingly similar in the allegations of uncontrollable bleeding being leveled at the manufacturers, it consolidated the cases together, which now contains over 2,800 complaints. In the month of August 2015 alone, the cases included in the multidistrict litigation (MDL 2592 in Louisiana) have grown by 400 cases, and the MDL is expected to increase further.

In addition to the cases in the MDL, there is an additional group of lawsuits in excess of 550 that were consolidated into a mass tort group by the Court of Common Pleas in Philadelphia, PA. All plaintiffs in these cases have named Janssen and Bayer AG as defendants as well.

FDA investigation

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body (possibly including examination of the recent studies that prompted the FDA investigation), as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.

AndroGel causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety.

Defendants engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel. Further, Defendants engaged in an aggressive unbranded ―disease awareness‖ campaign to alert men that they might be suffering from ―low T or ―low testosterone.

Plaintiff Thomas Henning of Lansdale, Pennsylvania used AndroGel, according to his prescription, from May 2011 to February 2014. 60. On May 10, 2012, he suffered a STEMI – i.e., an ST segment elevation myocardial infarction – which is a heart attack that results when a coronary artery becomes completely blocked by a blood clot. Prior to using AndroGel, Plaintiff had no history of myocardial infarction or other heart attack.

Attorney Ernest Cory of Cory Watson Attorneys argued a motion on behalf of plaintiffs before the Judicial Panel of Multidistrict Litigation on March 31, 2016, asking the panel to consider a request that all Viagra melanoma cases filed in federal courts be consolidated. The federal judges on the MDL panel issued today’s Transfer Order based on hearing arguments from attorneys for Pfizer and from attorneys representing plaintiffs. Attorneys nationwide are involved in the litigation. The court proceedings have been assigned to the Honorable Richard Seeborg of the Northern District of California.

Failed to warn consumers about melanoma risk

The Transfer Order states that “These actions share actual questions arising out of the allegation that Viagra (sildenafil citrate) causes or increases the risk of developing melanoma and that defendant failed to warn consumers and health care providers of the alleged risk. Additionally, all actions rely principally on the same studies to support their claims. Issues concerning general causation, the background science, regulatory history, and marketing will be common to all actions. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert and other issues, and conserve the resources of the parties, their counsel, and the judiciary.”

Plaintiffs’ lawsuits, including Dennis Andrews v. Pfizer, Inc., United States District Court for the Northern District of California, Case No. 3:15-cv-4884, allege Pfizer knew Viagra posed a cancer risk, and purposely hid facts about the drug’s safety. The plaintiff also alleges that Pfizer failed to sufficiently test the link between the use of the drug and the risk of deadly melanoma before the drug was approved by the FDA. Additionally, Plaintiffs allege in the suit that that even when studies linked Viagra to an increased risk of melanoma, Pfizer failed to warn users about the important risks associated with Viagra use and instead, continued to spend millions of dollars to promote Viagra.

Researchers examined data from The Health Professionals Follow-up Study, a long-term study by the Harvard School of Public Health, which tracked the data of nearly 26,000 men from 1986 through 2000. The researchers looked at both the instances of melanoma in these men as well as their reported Viagra use.

Even after controlling for factors like a history of skin cancer and UV light exposure, men who had taken Viagra were significantly more likely to develop melanomas than those who did not. Of the men who never used Viagra, 4.3 out of every 1,000 developed melanoma skin cancer. Of the men who reported using the erectile dysfunction drug, 8.6 men out of every 1,000 developed melanoma–an 84% increase.

Nearly 400 peripheral lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue to move forward in the federal multidistrict litigation in U.S. District Court in Minnesota. The proceeding convened its most recently monthly Status Conference on May 18th, when it was reported that 383 cases were pending in the federal litigation.

An additional 39 claims make similar allegations about the potential for fluoroquinolone antibiotics to cause peripheral neuropathy (disease or dysfunction of one or more peripheral nerves, typically causing numbness or weakness) and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The Plaintiffs have submitted a proposed bellwether case protocol to the Court. The next status conference is set for July 13 or July 28, 2016.

Fluoroquinolone Side Effects

Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat pneumonia, sexually transmitted diseases, E. coli, staph and other serious bacterial infections. Plaintiffs allege that the manufacturers failed to provide doctors and patients with adequate warnings about their potential to cause serious nerve damage, including permanent neuropathy.

A mention of these complications was added to the drugs’ labeling in 2004. However, the U.S. Food & Drug Administration (FDA) ordered their manufacturers to strengthen the labels in 2013 to better reflect the rapid onset of symptoms, as well as the potential for permanence. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)

On May 12, 2016, the FDA required labeling changes for fluoroquinolones, including an updated boxed warning, stating that the serious side effects associated with the antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effect can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA is also requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.